Premises
1. The premises shall be designed or adapted to ensure that the required storage conditions are maintained. They shall be suitably secure, structurally sound and of sufficient capacity to allow safe storage and handling of the veterinary medicinal products. Storage areas shall be provided with adequate lighting to enable all operations to be carried out accurately and safely. Veterinary medicinal products shall be stored suitably spaced to permit cleaning and inspection. Pallets shall be kept in a good state of cleanliness and repair.
2. Where premises are not directly operated by the persons referred to in Article 1(2), a contract shall be in place. The persons referred to in Article 1(2) may only use contracted premises if those premises are covered by a separate wholesale distribution authorisation.
3. Veterinary medicinal products shall be stored in segregated areas that are clearly marked and have access restricted to authorised personnel.
4. Any system replacing physical segregation, as applicable, such as electronic segregation based on a computerised system, shall provide equivalent security and shall be subject to appropriate validation.
5. Veterinary medicinal products pending a decision as to their disposal, or veterinary medicinal products that have been removed from saleable stock, shall be segregated physically or, if an equivalent electronic system is available, electronically, including returned veterinary medicinal products.
6. Veterinary medicinal products received from a third country but not intended for the Union market shall be segregated physically and electronically, if an electronic system is available.
7. Any expired veterinary medicinal products, recalled veterinary medicinal products and rejected veterinary medicinal products shall immediately be segregated physically and stored in a dedicated area away from all other veterinary medicinal products. The appropriate degree of security shall be applied in those areas to ensure that such items remain separate from saleable stock. Those areas shall be clearly identified.
8. The premises shall be designed or adapted to ensure that veterinary medicinal products subject to specific storage and handling measures, such as narcotics and psychotropic substances, are stored in accordance with written instructions and subject to appropriate security measures.
9. One or more dedicated areas shall be provided and appropriate safety and security measures shall be in place for the storage of hazardous veterinary medicinal products, as well as veterinary medicinal products presenting special safety risks of fire or explosion, such as medicinal gases, combustibles, flammable liquids and solids.
10. Receiving and dispatch bays shall protect veterinary medicinal products from prevailing weather conditions. There shall be adequate separation between the receipt and dispatch and storage areas. Procedures shall be in place to maintain control of inbound and outbound goods. Reception areas where deliveries are examined following receipt shall be designated and suitably equipped.
11. Unauthorised access to all areas of the authorised premises shall be prevented by appropriate devices such as a monitored intruder alarm system and appropriate access control. Visitors shall be accompanied at all times.
12. Premises and storage facilities shall be clean and free from litter and dust. Cleaning programmes, instructions and records shall be in place. Appropriate cleaning equipment and cleaning agents shall be chosen and used so as not to present a source of contamination.
13. The premises shall be dry and maintained within acceptable temperature limits.
14. There shall be appropriate procedures for the clean-up of any spillage to ensure complete removal of any risk of contamination.
15. Vehicles shall be cleaned regularly. Equipment chosen and used for the cleaning of vehicles shall not constitute a source of contamination.
16. Premises shall be designed and equipped in order to afford protection against the entry of insects, rodents or other animals. A preventive pest control programme shall be in place.
17. Rest, wash and refreshment rooms for employees shall be adequately separated from the storage areas. The presence of food, drink, smoking material or medicinal products for personal use shall be prohibited in the storage areas.
Temperature and environmental control
1. Suitable equipment and procedures shall be in place to check the environment where veterinary medicinal products are stored. Environmental factors to be considered include temperature, light, humidity and cleanliness of the premises.
2. An initial temperature mapping exercise shall be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment shall be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations. The mapping exercise shall be repeated according to the results of a risk assessment exercise or whenever significant modifications are made to the facility or the temperature controlling equipment. For small premises of a few square meters that are at room temperature, an assessment of potential risks, such as heaters, shall be conducted and temperature monitors shall be placed accordingly.
Equipment
1. All equipment with an impact on storage and distribution of veterinary medicinal products shall be designed, located and maintained to a standard suitable for its intended purpose. Planned maintenance shall be in place for key equipment vital to the functionality of the operation.
2. Equipment used to control or to monitor the environment where the veterinary medicinal products are stored shall be subject to calibration at defined intervals based on a risk and reliability assessment.
3. Calibration of equipment shall be traceable to a national or international measurement standard. Appropriate alarm systems shall be in place to provide alerts when there are excursions from pre-defined storage conditions. Alarm levels shall be appropriately set and alarms shall be regularly tested to ensure adequate functionality.
4. Equipment repair, maintenance and calibration operations shall be carried out in such a way that the integrity of the veterinary medicinal products is not compromised.
5. Defective vehicles and equipment shall not be used and shall either be labelled as such or removed from service.
6. Equipment not relevant for the wholesale activities shall not be stored in the area where veterinary medicinal products are stored.
7. Adequate records of repair, maintenance and calibration activities for key equipment, such as cold stores, monitored intruder alarm and access control systems, refrigerators, thermohygrometers, or other temperature and humidity recording devices, air handling units and any equipment used in conjunction with the onward supply chain, shall be made and the results shall be retained.
Computerised systems
1. Before a computerised system is brought into use, it shall be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, consistently and reproducibly.
2. A written, detailed description of the computerised system shall be available, including diagrams where appropriate. That description shall be kept up to date. The document shall describe principles, objectives, security measures, system scope and main features, how the system is used and the way it interacts with other systems.
3. Data shall only be entered into the computerised system or amended by persons authorised to do so.
4. Data shall be secured by physical or electronic means and protected against accidental or unauthorised modifications. Stored data shall be checked periodically for accessibility. Data shall be backed up at regular intervals. Backup data shall be retained at a separate and secure location for at least 5 years or for the period stated in the applicable national law, if that period is longer than 5 years.
5. Procedures to be followed if the system fails or breaks down shall be defined. This shall include systems for the restoration of data.
Qualification and validation
1. The persons referred to in Article 1(2) shall identify what key equipment qualification and key process validation is necessary to ensure their correct installation and operation. The scope and extent of such qualification and validation activities such as storage, picking and packing processes, shall be determined using a documented risk assessment approach.
2. Equipment and processes shall be subject to qualification or validation, respectively, before commencing use and after any significant changes, such as repair or maintenance.
3. Qualification and validation reports shall be prepared summarising the results obtained and commenting on any deviations observed. The principles of CAPA shall be applied, where necessary. Evidence of satisfactory validation and acceptance of a process or piece of equipment shall be produced and approved by appropriate personnel.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
